TRiCares has announced it has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to conduct a pivotal clinical trial for Topaz, its transcatheter tricuspid valve replacement (TTVR) system in the USA, Canada, and select sites in Europe.
The IDE approval marks a significant regulatory milestone for TRiCares, enabling the company to initiate its US pivotal trial and progress towards FDA market approval and US commercialisation of Topaz. The randomised trial, to be conducted at up to 75 investigative sites, will evaluate the safety and effectiveness of Topaz in patients with severe or greater tricuspid regurgitation (TR) who are at increased operative risk.
This pivotal trial approval builds on the clinical progress made in the US early feasibility study (EFS) and the ongoing TRICURE European pivotal study, which is currently enrolling patients at sites across Belgium, Denmark, France, Germany, Spain, and Canada with Switzerland to follow.
In May 2025, TRiCares shared encouraging first-in-human data demonstrating significant elimination of TR to grade trace/none (0) or mild (1+) in patients implanted with Topaz. No patients required a permanent pacemaker and the average procedure time was 35 minutes. These results have been subsequently published in EuroIntervention.
Ahmed Elmouelhi, president & CEO of TRiCares, said: “Receiving FDA approval for our US IDE pivotal trial marks a significant milestone for TRiCares and, most importantly, for the many patients living with tricuspid regurgitation who urgently need improved treatment options. This approval allows us to approach our investigator sites and prepare for first patient enrolments, bringing us closer to realising our ambition of making Topaz the standard of care for patients across the USA. Combined with the momentum we are seeing in our European pivotal study, Topaz has the potential to transform treatment outcomes for TR patients globally.”
“The FDA’s decision to grant IDE approval for the Topaz pivotal trial underscores the strength of the clinical evidence generated to date and the compelling unmet need in tricuspid regurgitation,” commented Pradeep Yadav (Piedmont Heart Institute, Atlanta, USA), co-principal investigator of the TRICURE US pivotal trial. “TTVR is rapidly emerging as a preferred treatment option for symptomatic patients with TR. We have been highly impressed with Topaz’s next-generation design, which enables streamlined implantation while maintaining a strong focus on safety and adaptability across complex patient anatomies. We are extremely excited and look forward to collaborating closely with the TRiCares team to advance this important pivotal study across US structural heart centres, ultimately improving patient outcomes.”
Neil Fam (University of Toronto, Toronto, Canada), co-principal investigator of the TRICURE US pivotal trial added: “This IDE approval is an important step forward in combating structural heart disease. Tricuspid regurgitation remains significantly undertreated, and the ability to conduct a rigorous, randomised US pivotal study with Topaz will be critical to support broad clinical adoption. The early clinical data from the US/Canadian EFS, the EU FIH, and the EU pivotal study have been encouraging and have significantly reduced the burden of procedural imaging. I look forward to this next phase of the programme.”
